Precision Montage ™ MRI SC-1210BRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729907114), received between Mar 6, 2017 and Aug 11, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Charging Problem” (6 reports).

17 other recalls cover devices cleared under the same FDA submission (P030017); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2026Unexpected Therapeutic Results

  It was reported that the patient experienced inadequate pain relief from the device. Additionally, increasing the stimulation to higher settings resulted in undesired sensations, including foot twitching and a rubber band-like sensation, which made walking difficult. The patient underwent Implantable Pulse Generator (IPG) explant procedure.

  Patient problems: Burning Sensation; Inappropriate Device Stimulation of Tissue; Pain

  MAUDE report 50201441 ↗
• InjuryDec 12, 2025Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem; Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REMOVED FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED AT THIS TIME. ADDITIONAL INFORMATION WAS RECEIVED THAT THE IPG WAS NO LONGER WORKING. THE PATIENT EXPERIENCED A RETURN OF THEIR PAIN AND WANTED A PRIMARY CELL BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 23796703 ↗
• InjuryNov 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23472273 ↗
• InjuryOct 16, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DIFFICULTY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23313966 ↗
• InjuryAug 9, 2025High impedance; Adverse Event Without Identified Device or Use Problem; High impedance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE PHYSICIAN REPLACED THE IMPLANTABLE PULSE GENERATOR (IPG). THE CURRENT LOCATION OF THE EXPLANTED IPG REMAINS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE. ADDITIONAL DETAILS CONFIRMED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT UNDERWENT AN EXPLANT PROCEDURE AS PART OF AN ELECTIVE DEVICE REPLACEMENT. THE PATIENT IS RECOVERING WELL POSTOPERATIVELY AND HAS EXPRESSED SATISFACTION WITH THE ONGOING THERAPY. IN ACCORDANCE WITH FACILITY POLICY, THE EXPLANTED DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED. ADDITIONAL INFORMATION CONFIRMED HIGH IMPEDANCES WERE FOUND ON THE LEADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22766512 ↗
• InjuryJun 10, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) PATIENT REPORTED CHARGING DIFFICULTIES. THE PATIENT UNDERWENT A PROCEDURE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED. IT WAS REPORTED THAT ELECTROCAUTERY WAS USED. THE PATIENT IS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED PER FACILITY POLICY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22179612 ↗
• InjuryMay 23, 2025Charging Problem; Charging Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) DEVICE WAS REPLACED DUE TO CHARGING DIFFICULTIES. THE PATIENT UNDERWENT AN IMPLANTABLE PULSE GENERATOR (IPG) REVISION PROCEDURE WHEREIN THEIR IPG WAS EXPLANTED AND REPLACED. THE IPG WAS RETAINED DUE TO HOSPITAL POLICY AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077958 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SPINAL CORD STIMULATION (SCS) SYSTEM UNDERWENT A REVISION PROCEDURE FOR AN UNKNOWN REASON. THE CURRENT LOCATION OF THE DEVICE REMAINS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED AND NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21981303 ↗
• InjuryApr 21, 2025Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO GET ENOUGH PAIN RELIEF FROM THE SPINAL CORD STIMULATOR (SCS) DEVICE. THE PATIENT UNDERWENT AN SCS EXPLANT PROCEDURE WHERE IN ALL DEVICES WERE REMOVED. THE EXPLANTED DEVICE WILL NOT BE RETURN DUE TO FACILITY POLICY.

  Patient problems: Pain

  MAUDE report 21878345 ↗
• InjuryDec 30, 2024Charging Problem; Adverse Event Without Identified Device or Use Problem; Charging Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO CHARGING DIFFICULTIES AND MAGNETIC RESONANCE IMAGING (MRI) ACCESS. REPLACEMENT WENT AS PLANNED. DEVICE WILL NOT RETURN BECAUSE IT WAS DISPOSED OF ACCORDING TO HOSPITAL POLICY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED, PATIENT WAS DOING WELL IN RECOVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043493 ↗
• InjuryNov 29, 2024Charging Problem; Charging Problem

  IT WAS REPORTED THAT THE PATIENT WAS FREQUENTLY CHARGING THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT AN IPG REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICE WAS RETAINED BY THE FACILITY AND WILL NOT BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20809898 ↗
• InjurySep 22, 2022Unexpected Therapeutic Results; Unexpected Therapeutic Results

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION AFTER HAVING THE SPINAL CORD STIMULATOR (SCS) SYSTEM IMPLANTED FOR THREE YEARS. THE PATIENT UNDERWENT A REVISION PROCEDURE TO EXPLANT THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Inadequate Pain Relief

  MAUDE report 15468494 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE WIFE OF THE PATIENT THAT THE PATIENT EXPERIENCED SEPSIS THREE TIMES IN 2018. WHILE THE PATIENT HAD BEEN WAITING TO HAVE SURGERY TO REMOVE THE SPINAL CORD STIMULATOR, THE PATIENT HAD BEEN HOSPITALIZED. THE PATIENT DID THEN HAVE THE SPINAL CORD STIMULATOR EXPLANTED AND IT WAS FOUND THAT THE SEPSIS HAD BEEN IN THE SPINAL CORD STIMULATOR. DURING THE TIME THAT THE PATIENT WAS HOSPITALIZED THE PATIENT BECAME PARTIALLY PARALYZED AND BY THE TIME THE EXPLANT SURGERY WAS COMPLETED HE WAS PARALYZED FROM THE CHEST DOWN. THE WIFE OF THE PATIENT NOTED THAT THE IMPLANTING PHYSICIAN ASSESSED THE DEVICE WAS NOT THE CAUSE OF THE REPORTED EVENTS. THE PATIENT UNDERWENT REHABILITATION WHICH WAS UNSUCCESSFUL AND THEN WAS PLACED IN A LONG TERM CARE FACILITY. THE LOCATION OF THE EXPLANTED DEVICE IS UNKNOWN.

  Patient problems: Paralysis; Sepsis

  MAUDE report 15353114 ↗
• InjurySep 20, 2018Migration; Migration

  A REPORT WAS RECEIVED THAT THE PATIENTS IPG HAD MIGRATED TOWARDS THE SPINE AND WAS CAUSING PAIN. THE PATIENT UNDERWENT A POCKET REVISION PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

  Patient problems: No Code Available; Pain

  MAUDE report 7894082 ↗
• InjuryDec 14, 2017Migration or Expulsion of Device; Charging Problem; Migration or Expulsion of Device; Charging Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AND TENDERNESS AT THE IPG SITE. IT WAS NOTED THAT THE PATIENT ALSO HAD DIFFICULTY CHARGING THE IPG DUE TO MIGRATION. THE PATIENT WILL UNDERGO A REVISION PROCEDURE.

  Patient problems: Discomfort; Pain

  MAUDE report 7116926 ↗
• InjuryMar 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE POCKET SITE. THE PATIENT WILL UNDERGO A POCKET REVISION PROCEDURE.

  Patient problems: Pain

  MAUDE report 6380972 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P030017. One submission often covers many models, so check the product and lot details in each record.

• Z-2879-2026 · Jun 17, 2026 · Open, Classified
  INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spin
• Z-2404-2026 · Apr 29, 2026 · Open, Classified
  Boston Scientific Model SC-4318, Clik X Anchor REF: M365SC43180
• Z-2617-2024 · Jul 17, 2024 · Open, Classified
  WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
• Z-2121-2020 · Apr 24, 2019 · Terminated
  LinearTM 3-4 50 cm 8 Contact Lead Kit, part number M365SC2352500. Leads function as a component of Boston Scientific's Spinal Cord Stimulation (SCS) systems by delivering electric
• Z-2122-2020 · Apr 24, 2019 · Terminated
  The LinearTM 3-4 70 cm 8 Contact Lead Kit, part number M365SC2352700 is part of a spinal cord stimulation system for prescription use only as an aid in the management of chronic i
• Z-2124-2020 · Apr 24, 2019 · Terminated
  Fifty-five (55) cm 8 Contact Extension Kit, part number M365SC3138550 - Product Usage: Lead Extensions are designed to connect the percutaneous leads to the Implantable Pulse Gene
• Z-2123-2020 · Apr 24, 2019 · Terminated
  Precision TM M8 Adapter, 15 cm, part number M365SC9218150 - Product Usage: The adapter is part of a spinal cord stimulation system for prescription use only indicated as an aid in
• Z-2119-2020 · Apr 24, 2019 · Terminated
  ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left
• Z-2120-2020 · Apr 24, 2019 · Terminated
  Thirty-five (35) cm 8 Contact Extension Kit, part number M365SC3138350. Package Contents: Lead Extension Kit (1) Lead Extension (1) Hex Wrench (1) Tunneling Tool Assembly (1) Devic
• Z-1409-2010 · Mar 19, 2010 · Terminated
  Bionic NAVIGATOR Clinician Programmer Model Number SC-7150-4
• Z-0271-2009 · Sep 22, 2008 · Terminated
  Precision Charger 1.0 (Model Number SC-5300) for the Precision Spinal Cord Stimulator System labeled as BIONICS SCS-CHARGING KIT CONTENTS Charger (1) Base Station (1) Belt Po
• Z-1441-2012 · Apr 22, 2008 · Terminated
  OMG (Observational Mechanical Gateway) Connector - A Model Number SC-9305 The Precision Spinal Cord Stimulator System is indicated as an aid in the management of chronic intractabl
• Z-0960-2008 · Oct 5, 2007 · Terminated
  Advanced Bionics Precision Implantable Pulse Generator Kit, Model Number: SC-1110 with firmware version prior to Revision 3.02, Advanced Bionics Corportation, Sylmar, CA 91342
• Z-0055-2008 · Aug 3, 2007 · Terminated
  Precision Implantable Pulse Generator (IPG), Model Number SC-110
• Z-0700-2007 · Jan 30, 2007 · Terminated
  The Precision Implantable Pulse Generator, Model Number SC-1110

…and 2 more.